The latest in off-label drug use

Stephen Tyring, MD, Medical Director, Dermatological Association of Texas and the Center for Clinical Studies, Clinical Professor, Departments of Dermatology, Microbiology/Molecular Genetics, and Internal Medicine (Division of Infectious Diseases) at the McGovern School of Medicine at the University of Texas Health Sciences Center, Houston kicked off its off-label drug use session at the SDPA 2022 Annual Summer Conference with a recent example of the Wrong off-label use of a drug: hydroxychloroquine.

The drug, which is indicated for malaria, lupus and rheumatoid arthritis, was used early in the COVID-19 pandemic but provided no benefit for the virus and in fact caused adverse effects, including ocular, hematological and allergic. His message? Proceed with caution. “Off-label use may be the wrong path, especially at the wrong dosage and for the wrong age group,” Tyring pointed out.

Antibiotics, Tyring noted, are commonly used off-label, used by nearly every branch of medicine. In dermatology, they have been used to excessively treat acne or rosacea. Drugs such as oral erythromycin, clindamycin, penicillin, and others have often been used off-label for the treatment of acne.

With antibiotics in particular, Tyring reminds the public that “even FDA-approved antibiotics can cause major problems if not used appropriately,” and, given that antibiotic resistance is such a current concern , this is a crucial thing to consider. Antimicrobial resistance is a public health problem, with the continued rise in resistance expected to kill 10,000,000 people a year by 2050.

Tyring developed the history of antimicrobial resistance, noting the emergence and mechanisms of resistance, as well as current emerging bacterial diseases, such as ticks (infectious and non-infectious) and rickettsial diseases, as well as re-emerging infectious diseases (MRSA and Treponema pallidum).

Overcoming antimicrobial resistance is crucial, Tyring says, along with factors such as biofilms and the microbiome; phytocompounds are currently the subject of more in-depth studies; and new drug delivery systems being tested, including those that use nanoparticles.

The most effective first response to antimicrobial overuse, Tyring says, are vaccines. “Vaccines decrease the need to treat infections,” which helps contain or eradicate community-based infectious diseases.

The sobering news is that dermatologists prescribe more antibiotics than any other specialty, using them to treat a wide variety of skin conditions, but there are responsible ways to do it.

Tyring reminded providers to always use directed therapy for the appropriate microbe, adjust drug dosages to an effective level, prescribe wisely, and provide education on antibiotic use to your patients.

Tyring then turned to using popular retinoids, such as acitretin (for pustular and plaque psoriasis), isotretinoin (for acne), and bexarotene (for cutaneous T-cell lymphoma) . Off-label uses of these drugs include rosacea, Darier’s disease, lichen planus, and chronic hand eczema.

With topical use of retinoids, adverse effects may include irritation, erythema, scaling, burning sensation, and pruritus.

Tyring also shared off-label uses of dupilumab for autoimmune bullous disease. These conditions are often treated with topical or oral corticosteroids, as well as biologics like dupilumab and rituximab.

Important points to remember: off-label prescribing is a common practice and sometimes necessary, but always:

  • Inform the patient if the drug is off-label
  • Inform the patient of alternatives, if available
  • Inform the patient of the potential benefits and risks

In closing, Tyring reminded session participants that whenever considering off-label drug use, always keep in mind the most important part of the Hippocratic Oath: not to harm.

Reference

1.Tying SK. Presented at the Society for Dermatology Physician Assistants Annual Summer Meeting. June 16-19, 2022. Austin, TX.